With
Carl Hittinger,
Lee Rosebush,
S. Maurice Valla
Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications.
With
Joel Gottesman
On January 22, 2016, the Food and Drug Administration (FDA) issued draft guidance on cybersecurity risks associated with medical devices, and addressed steps that device manufacturers should take to mitigate such risks.
With
Nita Garg
On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research.
With
Darby Allen,
Kathlynn Butler Polvino,
Donna Clark,
Nita Garg,
Dena Kessler,
Aaron Rabinowitz,
Lee Rosebush,
Lynn Sessions,
Jennifer Whitton
The U.S. Court of Appeals for the Fourth Circuit recently upheld the judgment against Tuomey Healthcare System, Inc. in a qui tam False Claims Act case predicated on Stark Law violations.
With
Nita Garg
The House Energy and Commerce Committee unanimously approved H.R. 6, the "21st Century Cures Act," on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill).
With
Dena Kessler
The House of Representatives and the Senate are assessing significant reforms to the Food, Drug and Cosmetic Act.
With
Cory Fox
On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI).
